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by devonEnlis 2783 days ago
"fraud product" - Do you mean the product that has been FDA approved for 6 years? Is the FDA "in" on the fraud? Is the New England Journal of Medicine in too?

Does having one product (that sold $xxx mil last year) make a bad company? Or one that put all of it's chips into this long term outcomes study? (which has now paid off)

Why do you care so strongly about this?
2 comments
coldtea 2783 days ago
>"fraud product" - Do you mean the product that has been FDA approved for 6 years? Is the FDA "in" on the fraud?

No, but something can be both FDA approved and fraud, e.g. snake oil. It just can't be particularly dangerous.

>Why do you care so strongly about this?

Wasn't you who devoted 4-5 arguments to a single comment the parent made? Why add this pop-psychology facile dismissal? What does "care so strongly" even means as an argument?

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devonEnlis 2782 days ago
Trying to understand the commenter's motivations. This product has reduced cardiovascular death - if his fraud conspiracy theory convinces appropriate patients not to take it, it could literally kill people.
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coldtea 2782 days ago
First time hearing about the product, but looking at the facts, the parent seems to be right. It's more snakeoil than product. Your argument was that FDA approved it, but here's the actual story:

"On 10/16/2013 after FDA's ADCOM panel had voted 9-2 against recommending to expand Vascepa's label for treatment of cardiovascular disease, shares dropped over 60%"

"In March 2016, after losing a court case, the FDA agreed to allow some off-label marketing"

So, it's not like FDA approved it as a drug for cardiovascular disease. They overwhelmingly rejected it as so, and then were forced to allow it to market it self off-label as such (for "free speech" purposes, as opposed for medical reality).

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raspasov 2782 days ago
No better than regular fish oil but costs hundreds of dollars a month.

A way to scam money out of Medicare.

Using mineral oil in the study to make their product look superior.

I'm not the only one to share those concerns: https://www.forbes.com/sites/matthewherper/2018/11/10/fish-o...

The biomarkers of patients in the PLACEBO group decreased significantly (up to 30%). Why?

"But what seriously bothered five of the six cardiologists I spoke to was that the mineral oil had not behaved as a placebo at all. In other studies of cardiovascular drugs, blood test results on placebo do not budge. That’s not what happened here. Patients who received mineral oil saw their levels of low-density lipoprotein, the bad cholesterol, increase 10% to 84 milligrams per deciliter, 6% more than in the Vascepa group, according to the New England Journal of Medicine paper. What’s more, other blood test results used by cardiologists also went in the wrong direction. These changes were included in a supplement to the scientific paper, but not in the study itself. Levels of c-reactive protein, a measure of inflammation that is used to help calculate heart risk by some doctors, increased from 2.1 milligrams per liter to 2.8 milligrams per liter, a 30% increase. Could the placebo be causing some heart problems or strokes, making Vascepa look better than it really is?"

Shame on NPR for the sloppy reporting.

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